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FDA 510(k)

MRX-865

K-Number: K921130 · 1992-09-10

Decision Date1992-09-10
Product CodeITY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRX-865 is the device name listed in this FDA 510(k) record. The listed applicant is Mrx-Ray Tube Corp.. It received FDA 510(k) clearance on 1992-09-10 under 510(k) number K921130. The device is classified under product code ITY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRX-865?

MRX-865 is a medical device that received FDA 510(k) clearance on 1992-09-10. The listed applicant is Mrx-Ray Tube Corp.. The 510(k) number is K921130.

When did MRX-865 receive FDA 510(k) clearance?

MRX-865 received FDA 510(k) clearance on 1992-09-10, under 510(k) number K921130.

Who is the listed applicant for MRX-865?

The FDA 510(k) record lists Mrx-Ray Tube Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRX-865?

The FDA product code for MRX-865 is ITY.

Other records listing Mrx-Ray Tube Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: ITY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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